Table 1.

Measures and Related Time Points

	Baseline (visit 1)	Week 4 (visit 2)	Week 8 (visit 3)	Week 12 (visit 4)	Week 24 (visit 5)
Primary outcomes
12-Week continuous abstinence for weeks 9–12			x	x
Secondary outcomes
Sustained smoking reduction for weeks 9–12			x	x
24-Week continuous abstinence for weeks 9–24			x	x	x
Sustained smoking reduction for weeks 9–24			x	x	x
Vital signs (BP and HR)	x	x	x	x
Weight	x	x	x	x
SANS and SAPS	x	x	x	x
Adoption rate and adherence to product use		x	x	x
AEs	x	x	x	x
mCEQ	x	x	x	x
CO	x	x	x	x	x
FTCD	x

AEs = adverse events; BP = blood pressure; CO = exhaled carbon monoxide; FTCD = Fagerstrom test for cigarette dependence; HR = heart rate; mCEQ = Modified Cigarette Evaluation Questionnaire; SANS = Scale for the Assessment of Negative Symptoms; SAPS = Scale for the Assessment of Positive Symptoms.